Intarcia Announces New Top-Line Phase 3 Results For Investigational Therapy ITCA 650 In Type 2 Diabetes

BOSTON, Aug. 18, 2015 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced positive top-line results from its 52-week Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of the company's late-stage investigational candidate ITCA 650 to Merck's Januvia in reducing HbA1c in patients with type 2 diabetes following a year of treatment. All patients were on background metformin monotherapy. ITCA 650 is an injection-free GLP-1 receptor agonist in development that continuously delivers exenatide with just once or twice-yearly dosing via a small matchstick-size subdermally placed osmotic mini-pump. In the FREEDOM-2 trial, ITCA 650 met all primary and secondary endpoints, demonstrating superiority over Januvia at every measured time point through and including week 52 endpoints for reduction in HbA1c and reduction in body weight (BW). ITCA 650 is not yet being investigated for the management of obesity. Full details of the trial results will be submitted for publication and presentation at major medical meetings including data on the following:

• Significantly more patients on ITCA 650 60mcg versus Januvia 100mg achieved the secondary composite endpoint combining glucose reductions of > 0.5% and weight reductions of 2 kg or greater; ITCA 650 results were superior vs. Januvia 100mg
• Significantly more patients on ITCA 650 60mcg achieved the ADA-recommended HbA1c target of < 7.0% versus Januvia 100mg; ITCA 650 results were superior vs. Januvia 100mg

"These clinical results and the innovative method of administration represent a potential major advance for the entire type 2 diabetes community," said Robert R. Henry, M.D., Chief, VA Endocrinology & Metabolism, and Professor of Medicine in Residence at UCSD, and an investigator in the FREEDOM Phase 3 clinical trial program. "The comparative data leave little room for speculation about ITCA 650's potential value in a chronic disease where more than half of all patients are not at the recommended glycemic goal and not adherent to therapy over time. 

"If approved, ITCA 650 would be the first and only GLP-1 receptor agonist to offer a viable alternative to regular life-long injections, and, with once or twice yearly dosing, it has the potential to enhance patient compliance, which has also been a long-standing, unresolved problem and a major contributing cause of poor glycemic control over time. Given the epidemic nature of type 2 diabetes and the immense unmet need within this growing population, I'm extremely encouraged by these results for ITCA 650, and I'm hopeful that this much needed and long-awaited treatment option may be available in the near future."

In the FREEDOM-2 trial, ITCA 650 60 mcg/d also demonstrated an overall and G.I. tolerability profile similar to prior Phase 3 results recently presented at ADA in the FREEDOM-1 placebo-controlled trial. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the application site was less than 1% of all procedures in the trial.

Kurt Graves, Chairman, President and CEO of Intarcia, commented: "Our third Phase 3 trial results mark another major milestone for our company. The comparative results on all study endpoints for ITCA 650 vs. Januvia were unambiguous and compelling, particularly in light of how widely Januvia was prescribed worldwide last year, with global sales of more than $6 billion. What is even more exciting and important to me are the strength and sustained reductions demonstrated by our data over 52 weeks. The prospect of bringing a totally new therapeutic approach to the market that has shown a potential to reduce both HbA1c, by a mean 1.5%, and reduce weight, by a mean 4 kg, in the population studied is remarkable." Graves continued, "Add to that our planned once or twice-yearly dosing, a very important and new delivery alternative to daily pills and life-long self-injections that many patients have difficulty adhering to after just 3-6 months. ITCA 650 was designed with built-in compliance and adherence aspects that can really matter over time and future real-world comparative outcome studies will look to reinforce how this can potentially transform treatment outcomes in diabetes. To date, injectable type 2 diabetes medicines have really struggled to be used to any significant degree early in the disease after front-line metformin fails. Our FREEDOM-2 data clearly show our potential in this early post-metformin setting and our market research shows our novel dosing opens up a large segment of the market that injectable medications have only marginally penetrated. We look forward to working closely with global health authorities and our partners as we prepare ITCA 650 for regulatory filings in the first half of next year, and then to make it available to appropriate patients and the broader healthcare system."

Methodology and Scope of the FREEDOM-2 Clinical Trial
FREEDOM-2 was a multi-center, randomized, active comparator, double-blind, global Phase 3 trial with a 52-week treatment and a 4-week post-treatment follow-up period. The trial enrolled 535 adult patients with HbA1c levels greater than or equal to 7.5% and less than or equal to 10.5%. Patients were on background metformin monotherapy and randomized 1:1 to receive either ITCA 650 60 mcg/day following an introductory dose of ITCA 650 20 mcg/day, plus once-daily oral placebo, or once-daily oral Januvia 100 mg/day, plus ITCA 650 placebo. The primary endpoint was change in HbA1c between Week 52 and Day 0. With superiority demonstrated, secondary endpoints included the proportion of patients with a decrease in HbA1c of > 0.5% and greater than or equal to 2 kg weight loss between Week 52 and Day 0, change in body weight between Week 52 and Day 0 and proportion of patients with HbA1c < 7% measured at Week 52.

Intarcia recently presented the full results from its successfully completed FREEDOM-1 and FREEDOM-1 HBL (high baseline) Phase 3 clinical trials at the 75^th Scientific Sessions of the American Diabetes Association. Intarcia is currently conducting one final Phase 3 trial, FREEDOM-CVO, a global, placebo-controlled cardiovascular outcomes study examining the safety of ITCA 650 at 60 mcg/day versus placebo in approximately 4,000 patients on a variety of approved anti-diabetic therapies; this trial is fully enrolled and ongoing.

About ITCA 650
ITCA 650 is being developed for the treatment of type 2 diabetes, combining Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. If approved, ITCA 650 would represent the first injection-free GLP-1 therapy capable of delivering up to a full year of treatment from a single subdermal placement of the osmotic mini-pump. ITCA 650 is currently in a global Phase 3 clinical trial program called FREEDOM.

About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is an independent, privately held, biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once or twice yearly has the potential to ensure improved patient adherence and compliance, which is otherwise difficult to achieve in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform. Intarcia is conducting a Phase 3 development program for type 2 diabetes that consists of four separate clinical trials, three of which have now been completed. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic serious disorders in the field of diabetes, obesity and autoimmune diseases. For more information on Intarcia, please visit www.intarcia.com

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